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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K926399
Device Name CUTIFILM(R) FILM
Applicant
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact KENNETH M NICOLL
Correspondent
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact KENNETH M NICOLL
Classification Product Code
MGP  
Date Received12/21/1992
Decision Date 11/15/1993
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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